boxed warning
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CounterAct IB
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- CounterAct IB
- Generic name
- IBUPROFEN
- Manufacturer
- Melaleuca, Inc
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 7fafc13e-3fee-ace3-e053-2a91aa0ac2ea
- SPL ID
- 4d4001f1-0e22-4f9a-e063-6394a90ae123
- Version
- 5
- Effective date
- 2026-03-17
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:11
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 072096 | derived:openfda.application_number |
| application number | ANDA072096 | openfda.application_number | |
| brand name | CounterAct IB | openfda.brand_name | |
| generic name | IBUPROFEN | openfda.generic_name | |
| manufacturer name | Melaleuca, Inc | openfda.manufacturer_name | |
| ndc | package | 54473-306-50 | openfda.package_ndc |
| ndc | product | 54473-306 | openfda.product_ndc |
| ndc11 | package | 54473030650 | derived:openfda.package_ndc |
| rxcui | 1101919 | openfda.rxcui | |
| rxcui | 310965 | openfda.rxcui | |
| spl id | 4d4001f1-0e22-4f9a-e063-6394a90ae123 | id | |
| spl set id | 7fafc13e-3fee-ace3-e053-2a91aa0ac2ea | set_id | |
| unii | WK2XYI10QM | openfda.unii |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe bleeding. The chances are higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.